Does Wearing Tetra-Grip Improve Arm Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?

NCT ID: NCT03647761

Last Updated: 2022-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2022-05-18

Brief Summary

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This study evaluates the effect of wearing a tetra-grip on the affected arm of children with neonatal brachial plexus palsy. Half of the participants will have tetra-grip applied to the arm, while the other half will not have it applied to the arm.

Detailed Description

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Tetra-grip is a tubular elastic support bandage that provides both compression and support. Previous studies have shown that by applying neoprene or athletic tape to a joint on individuals with poor proprioception or a history of joint injury, such modalities enhanced their proprioceptive recognition via stimulation of mechanoreceptors responding to skin stretch and compression during joint motion. As a result, patients have greater kinesthetic and joint position awareness of their limb.

Conditions

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Neonatal Brachial Plexus Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment

Tetra-grip applied

Group Type EXPERIMENTAL

Tetra-grip

Intervention Type DEVICE

Tetra-grip is a tubular elastic bandage that provides both compression and support

Interventions

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Tetra-grip

Tetra-grip is a tubular elastic bandage that provides both compression and support

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 3 - 7 years old
* male or female
* non-dominant upper extremity brachial plexus injury

Exclusion Criteria

* Botox injections to the affected extremity within the past 3 months
* Severe muscle contractures of affected extremity that restricts functional use of the arm and hand
* Concurrent cerebral palsy
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Robert Rinaldi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Medical Center Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU 022018-069

Identifier Type: -

Identifier Source: org_study_id

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